Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2026-01-16 @ 7:21 AM
Study NCT ID:
NCT01461603
Status:
UNKNOWN
Last Update Posted:
2016-03-03
First Post:
2011-10-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Local Effects of Amino Acids and 3-hydroxybutyrate in the Bilaterally Perfused Human Leg
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C545824', 'term': 'amino-acid, glucose, and electrolyte solution'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-02', 'studyFirstSubmitDate': '2011-10-19', 'studyFirstSubmitQcDate': '2011-10-26', 'lastUpdatePostDateStruct': {'date': '2016-03-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in muscle metabolism after administration of amino acids.', 'timeFrame': 'Basal period and a glucose clamp (6 hours pr.day)', 'description': 'Measured by arterio-venous differences of isotope tracers'}], 'secondaryOutcomes': [{'measure': 'Intracellular mTOR and pAkt signal activation after infusion of amino acids.', 'timeFrame': 'Basal period and a glucose clamp (6 hours pr. day)', 'description': '4 muscle biopsies measured for mTOR and pAkt activation by western blotting'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['critical illness', 'protein metabolism', 'pharmaconutrients'], 'conditions': ['Critical Illness', 'Protein Metabolism', 'Pharmaconutrients']}, 'descriptionModule': {'briefSummary': 'Introduction: Protein loss during critical illness is an important problem and is shown to predict overall survival. In animal studies, infusion of leucine is shown to increase the synthesis of muscle protein by 30-40% and decrease protein degradation by 30%.\n\nObjectives: Compared to saline, an amino acid or 3hydroxybutyrate infusion in the femoral artery will promote protein synthesis and inhibit breakdown assessed with local a/v phenylalanine and tyrosine tracer kinetics in healthy volunteers. These effects will include distinct alterations in muscle signal events, in particular mTOR.\n\nMethods: n = 10 healthy male subjects are equipped with catheters in aa. femorals and vv. femorals bilaterally under local anaesthetics. Each study comprises a 3-hour basal period and a 3-hour period with hyperinsulinaemic-euglycaemic clamp. During the test, samples of arterial and venous blood and 4 muscle biopsies are obtained. The intervention contain continues saline infusion compared to either amino acids (Vamin) or 3hydroxybutyrate solution FFa-3OHB.\n\nPerspectives: This study elucidates the direct effect of aminoacids and ketone bodies on muscle protein metabolism in humans and contribute to further development of nutritional therapy in human catabolic states.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI between 19 and 28\n* Written consent before study start\n\nExclusion Criteria:\n\n* Diabetes\n* Inclusion in other studies using ionizing radiation.\n* Allergic to egg or soy'}, 'identificationModule': {'nctId': 'NCT01461603', 'briefTitle': 'Local Effects of Amino Acids and 3-hydroxybutyrate in the Bilaterally Perfused Human Leg', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Local Effects of Amino Acids and 3-hydroxybutyrate in the Bilaterally Perfused Human Leg', 'orgStudyIdInfo': {'id': 'M-20110177'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Amino acids', 'description': 'Amino acids compared to saline', 'interventionNames': ['Dietary Supplement: Vamin (Fresenius Kabi)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3hydroxybutyrat (3OHB)', 'description': 'Ketone body, 3OHB compared to saline', 'interventionNames': ['Dietary Supplement: 3hydroxybutyrate']}], 'interventions': [{'name': 'Vamin (Fresenius Kabi)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Vamin 18gN 1ml/min infusion in 6 hours', 'armGroupLabels': ['Amino acids']}, {'name': '3hydroxybutyrate', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['3OHB, 3hydroxybutyric acid'], 'description': 'Goldbio, FFA-3OHB, dry powder mixed with sterile water at Aarhus University hospital pharmacy.', 'armGroupLabels': ['3hydroxybutyrat (3OHB)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus C', 'country': 'Denmark', 'facility': 'M-researchlab. MEA, Aarhus University Hospital, NBG', 'geoPoint': {'lat': 56.16558, 'lon': 10.21231}}], 'overallOfficials': [{'name': 'Niels Møller, Professor, Dr.Med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Aarhus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}